MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. INQUIRY¿ OPTIMA¿ DIAGNOSTIC CATHETER; CATHETER, ELECTRODE RECORDING

Model Number	IBI-81659
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The shaft of the catheter was noted to be separated / detached at the end of the study.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
One duodecapolar, spiral loop, inquiry optima diagnostic catheter was received for evaluation.Visual inspection revealed multiple bends on the shaft proximal to the spiral loop.Additionally, the strain relief was bent and the catheter shaft was twisted and kinked proximal to the spiral loop/shaft transition.A tear in the catheter shaft was noted 2.10¿ proximal to the spiral loop/shaft transition exposing the spring body.The catheter deflected when actuating the steering mechanism; however, did not deflect in the correct shape and did not meet specification, due to the aforementioned condition of the shaft.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Further analysis revealed the cause of the kink and tear in the shaft is consistent with damage during use.

• Brand Name: INQUIRY¿ OPTIMA¿ DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 7743580
• Report Number: 2030404-2018-00053
• Device Sequence Number: 1405423
• Product Code: DRF
• UDI-Device Identifier: 05414734305150
• UDI-Public: 05414734305150
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K402775
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: IBI-81659
• Device Lot Number: 6108098
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1